Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union
TOKYO and CAMBRIDGE, Mass., July 29, 2024 – (JCN Newswire) – Eisai Co., Ltd. and Biogen Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Approval (MAA) for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab as treatment for early AD (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD).“We are extremely disappointed by the CHMP’s negative opinion and understand that this may also be disappointing for the wider Alzheimer’s disease (AD) community…
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